MedTrace Logo

Silver Graft All Comers Registry

NCT01970605 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2019-01-23

No results posted yet for this study

Summary

This web based e-Registry will be international, multi-center and prospective. Silver Graft e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient population

Conditions

  • Aneurysm
  • Graft Failure
  • Graft Infection

Interventions

PROCEDURE

Surgical reconstruction

In contrast to silver acetate impregnated vascular graft, Silver Graft can be immersed in an antibiotic containing solution prior to implantation. This practice should always be followed according to each participant's hospital guidelines and experience. The long term efficacy of the metallic silver coating will not be reduced. Common practice antibiotic co-medication before, during and after surgery needs to be documented but is at the discretion of each participating institution. Due to the registry character of this assessment, i.e. routine use of the investigational product, local antibiotics, e.g. dipping of the vascular graft into a rifampin solution is permissible.

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Jörg Tautenhahn, MD · Klinikum Magdeburg

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970605 on ClinicalTrials.gov